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TerminatedNCT03471013CroyAid-SCZUpdated Feb 11, 2026

Impact of Caregiver Beliefs on Adherence to Antipsychotic Medications in Patients With Schizophrenia

An observational study in DSM-5 Schizophrenia, sponsored by University Hospital, Clermont-Ferrand. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-11.

Sponsored by University Hospital, Clermont-Ferrand · Observational

Why this study was terminated
difficulty of recruitement
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study summary

Only one third of patients with schizophrenia are observant to their treatment knowing that the lack of adherence to treatment is one of the most important predictors of relapse.

Recent work shows that the erroneous or negative beliefs of patients with schizophrenia regarding antipsychotic treatment are associated with poor compliance.

The hypothesis is that negative beliefs about the antipsychotic treatment of caregivers of patients with schizophrenia may be associated with a higher risk of poor compliance compared to caregivers with positive beliefs about treatment.

The primary purpose is to explore the correlation between caregiver beliefs about treatment and patient compliance, taking into account the level of caregiver-patient link.

Read the detailed description

Non-interventional cross-sectional exploratory study with a single visit for patients with schizophrenia and their caregivers, who agreed to participate in the protocol.

02

Conditions studied

  • DSM-5 Schizophrenia

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Keywords

  • schizophrenia
  • beliefs
  • caregiver
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with a diagnosis of scizophrenia

Inclusion criteria

  • Patient over 18 years old
  • With a diagnosis of schizophrenia according to DSM-5 criteria
  • Accompanied by his main caregiver, who will be able to complete the questionnaires after having signed the information form.
  • Treated with one or more antipsychotics.
  • Able to complete the questionnaires related to the protocol
  • Having agreed to sign the information form.

Exclusion criteria

Exclusion Criteria:

  • Not understanding French, unable to answer questions linguistically
  • Presenting an organic pathology and / or cognitive deterioration likely to hinder a good understanding of the interview
  • Having already participated in the study
  • presenting disorders related to the use of substances of severe intensity (such as acute intoxication, withdrawal syndrome or any state of delirium)
04

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
50 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients and caregivers

    Patients suffering from schizophrenia accompanied by their caregiver

05

What researchers measure

Primary outcomes

  1. Assessment of the correlation between caregiver beliefs about treatment and patient compliance

    The caregiver beliefs are evaluated by the Beliefs about Medicines Questionnaire, the patient compliance is evaluated by the investigator with Behaviourally Anchored Rating Scales and by the patient him-self with Morisky Medication Adherence Scale, and the level of caregiver-patient link is evaluated with Involvement Evaluation Questionnaire.

    Time frame: At day 1

06

Study locations

1 site
  • Chu Clermont-Ferrand
    Clermont-Ferrand, 63003, France
07

Registry details

Key details

Study ID
NCT03471013
Lead sponsor
University Hospital, Clermont-Ferrand
Responsible party
Sponsor
First posted
Mar 20, 2018
Start date
Mar 20, 2018
Primary completion
Jul 10, 2025
Completion
Feb 2, 2026
Last update
Feb 11, 2026

Study contacts

Ludovic SAMALIN
principal investigator · University Hospital, Clermont-Ferrand

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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